NCT03552068: ID-CLO

Study of Clonidine Efficacy for the Treatment of Impulse Control Disorders in Parkinson's Disease:

Completed Phase 2 Last updated 3 September 2025

What this trial tests

Phase 2 trial testing placebo in Parkinson's Disease in 38 participants. Completed in 3 December 2021.

Timeline

15 May 2019

Primary endpoint
15 July 2021

3 December 2021

Quick facts

Lead sponsor	Hospices Civils de Lyon
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	38
Start date	15 May 2019
Primary completion	15 July 2021
Estimated completion	3 December 2021
Sites	1 location across France

Drugs / interventions tested

• placebo
• Clonidine (CLONIDINE) — full drug profile →

Conditions studied

• Parkinson's Disease — all drugs for Parkinson's Disease →
• Mpulse Control Disorders — all drugs for Mpulse Control Disorders →

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

Adults 30 to 80, any sex, with Parkinson's Disease or Mpulse Control Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Noradrenergic system is involved in impulsivity in the general population and is altered in Parkinson's disease (PD) in the early stages of the disease. Thus, targeting this system could be of interest in impulse control disorder (ICD). Acting on the noradrenergic system is possible using clonidine, an α2 adrenergic agonist largely used in hypertension treatment and that induces a decrease of NADR release. Thus, our aim is to conduct a proof of concept study evaluating the efficacy and safety of clonidine on ICD in PD. This study is a multicenter, randomized, double-blind, placebo-controlled in parallel group clinical trial.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. The neuropsychiatry of Parkinson's disease: advances and challenges.
   Weintraub D, Aarsland D, Chaudhuri KR, Dobkin RD, et al · · 2022 · cited 288× · PMID 34942142 · DOI 10.1016/s1474-4422(21)00330-6
2. Neuropsychiatric Disorders in Parkinson's Disease: What Do We Know About the Role of Dopaminergic and Non-dopaminergic Systems?
   Dujardin K, Sgambato V. · · 2020 · cited 29× · PMID 32063833 · DOI 10.3389/fnins.2020.00025
3. A High-Throughput Chemical Screen in DJ-1β Mutant Flies Identifies Zaprinast as a Potential Parkinson's Disease Treatment.
   Sanz FJ, Solana-Manrique C, Torres J, Masiá E, et al · · 2021 · cited 13× · PMID 34697772 · DOI 10.1007/s13311-021-01134-2
4. Efficacy and safety of clonidine for the treatment of impulse control disorder in Parkinson's disease: a multicenter, parallel, randomised, double-blind, Phase 2b Clinical trial.
   Laurencin C, Timestit N, Marques A, Duchez DD, et al · · 2023 · cited 12× · PMID 37338615 · DOI 10.1007/s00415-023-11814-y
5. Autophagy-targeted therapy to modulate age-related diseases: Success, pitfalls, and new directions.
   Martins WK, Silva MDND, Pandey K, Maejima I, et al · · 2021 · cited 11× · PMID 34909664 · DOI 10.1016/j.crphar.2021.100033